Download Investor Presentation – October 2014

Investor Presentation – October 2014
Forward Looking Statements
This presentation contains "forward-looking statements" which reflect the current expectations of management of the Company's
future growth, results of operations, technological development and implementation, performance and business prospects,
opportunities, and drug development programs. Wherever possible, words such as "may", "would", "could", "will", "anticipate",
"believe", "plan", "expect", "intend", "estimate”, “potential”, and similar expressions have been used to identify these forwardlooking statements. These statements reflect management's current beliefs with respect to future events and are based on
information currently available to management. Forward-looking statements involve significant risks, uncertainties and
assumptions. Many factors could cause the Company's actual results, performance, achievements or technological development
and implementation to be materially different from any future results, performance, achievements or technological development
and implementation that may be expressed or implied by such forward-looking statements, including, without limitation, those
listed in the "Risk Factors" section of the Company's Annual Information Form dated June 30, 2014 filed on SEDAR on October 8,
2014 and other information contained in the Company’s public filings (which may be viewed at www.sedar.com). Information
contained in this presentation is qualified in its entirety by such public filings. Should one or more of these risks or uncertainties
materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or
achievements may vary materially from those expressed or implied by the forward-looking statements contained in this
presentation. These factors should be considered carefully and prospective investors should not place undue reliance on the
forward-looking statements. Although the forward-looking statements contained in the presentation are based upon what
management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual
results, performance or achievements will be consistent with these forward-looking statements. This presentation does not
constitute an offer to sell any class of securities of the Company in any jurisdiction.
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Investment Highlights
• 
Addressing large markets with unmet medical needs
•  Gout and Rett Syndrome (rare disease)
•  Repurposing existing and proven drugs/orphan drugs focus
• 
De-risked later-stage clinical assets
•  Known safety (clinical/market use)
•  Patent protection to 2030’s
• 
Secured Pharma development partner for gout
•  Market validation and reduced development risk/cost
• 
Clear path to commercialization
•  Driven by phase II data and partnerships
• 
Significant near-term catalysts unlocking value
3
About Revive
• 
Clinical-stage company founded in 2012
• 
Drug repurposing with faster-to-market potential
•  Lower development risk, cost, known safety and manufacturing
•  Example: Viagra® (Pfizer) and Thalomid® (Celgene)
• 
Focus on repurposing non-U.S. drugs
•  Advantages of a new drug (i.e. market exclusivity)
• 
Validate assets in Phase 2 and seek Pharma deal
• 
Experienced team and board of directors
4
Team Overview
Management
•  Fabio Chianelli, CEO, Director
•  Generex Biotechnology Corp.
•  Titan Medical (TSXV: TMD)
•  Carmelo Marrelli, CA, CFO
•  Principal of Marrelli Support Services Inc.
•  Dr. Bev Incledon, PhD, VP of R&D
•  Eli Lilly Canada, Director of R&D
•  Dr. Albert Agro, PhD, Clinical Development
•  Cynapsus, CMO
Board of Directors
•  Craig Leon, Chairman
•  Titan Medical (TSXV: TMD), Chairman
and CEO
•  Redwood Asset, COO
•  Generex Biotechnology Corp.
•  William Jackson, Director
•  Atwill Medical Solutions, CEO
•  Covalon (TSXV: COV), CFO, COO,
Director
•  Titan Medical (TSXV: TMD), Director
•  Carlo Sansalone, Director
•  Dr. Robert Terkeltaub, MD, Principal Investigator
•  Sanscon Construction, President
•  UCSD Rheumatology Professor
•  Experienced PI in Gout Clinical Trials
•  Fabio Chianelli, CEO, Director
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Product Pipeline
•  De-risked assets, large markets, patent protection 2030’s
Product
Indication
Preclinical
Phase I
Phase IIA
REV-002 Gout
REV-003 Rett Syndrome (Rare disease)
2014
REV-001 Post-Op Pain
for out-licensing
Available
Phase IIB/
III
Q4/FY14
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Near-term Catalysts
Rett Syndrome
Orphan Drug
Designation
Start
Rett Syndrome
Phase 2a
Start
Gout
Phase 2a
Gout
Phase 2a
results
Q1-2015
Start Gout
Phase 2b
Q2-2015
Q1-2015
IND Filing Gout
Q1-2015
Q4-2014
Q4-2014
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Intellectual Property
•  Gout
•  PCT/CA2013/050882 - The use of bucillamine in the treatment of gout
•  Expires 2033
•  Acquired patent assignment from Xenexus Pharma (Xenexus earns
5% from upfront, milestones and royalties that is paid to Revive by
Pharma partner)
•  Rett Syndrome
•  PCT/GB2013/051213 - Treatment of respiratory depression
•  Expires 2033
•  Exclusive world-wide license from Numedicus Ltd (Numedicus earns
15% from upfront, milestones and royalties that is paid to Revive by
Pharma partner)
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1. Gout Opportunity
• 
Over 8 million adults (~3.9%) in USA with gout and 14 million worldwide with
gout (~18 million by 2021)
• 
Current anti-inflammatory drugs are often contraindicated
• 
Refractory arthritis increasingly common
• 
>50% do not reach uric acid lowering target, thus continue to experience acute
flares and develop chronic arthritis
• 
Drug limitations increases healthcare costs, therapy restarts, non-adherence,
discontinuations
• 
Gout prevalence markedly increasing, especially in patients with limited therapy
options
• 
Significant needs for drugs both to control inflammatory arthritis and lower uric
acid
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Gout
Over production
of uric acid
Hyperuricemia
High serum uric acid (sUA)
Monosodium Urate (MSU) crystals
deposited
Under excretion
of uric acid
Needle-like
crystals in joints
and/or soft tissues
Inflammatory response:
NF-κB signaling, IL-1, IL-6, chemokines
Painful acute gout flares
Leads to acute
attacks of severe
pain (flares) due to
inflammation
Chronic Arthritis/Joint damage
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Gout Management Objectives
Diagnose, Treat
and Prevent
Acute Gout
Flares
Identify,
Manage
Co-Morbidities
and Causes
of Hyperuricemia
Patient Education,
Treatment Adherence
Terkeltaub R. Nature Rev Rheumatology, 2010
Rees et al, ARD, 2012
Urate-lowering
drugs: Treat
to Target of Serum
Urate <6 mg/dL
At a Minimum
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Pharmacologic Options to
Treat Acute Gouty Inflammation
•  First-line options 1-4
–  NSAIDs (selective
Cox-2 inhibition)
–  Systemic
glucocorticosteroids
–  Oral colchicine (for
early in gout flare, lowdose regimen)
1. *Terkeltaub RA. N Eng J Med. 2003;349:1647-1655.
2. Schlesinger N, et al. Expert Opin Pharmacother. 2009;10:1319-28.
3. Terkeltaub R. Nat Rev Rheumatol. 2010;6:30-38.
4. Terkeltaub RA, et al. Arthritis Rheum, 2010;62:1060-1068.
ACTH = adrenocorticotropic hormone
•  Other options 1-4
–  Intra-articular
glucocorticosteroids
–  Synthetic ACTH 1,2,5
•  Off-label FDA, approved EMU
–  Biologic IL-1 antagonism
1,3,4,6,7
1, 2, 5: Schlesinger N. Overview of the management of acute gout and the role of adrenocorticotropic
hormone. Drugs. 2008;68(4):407-15.
6: So A, De Smedt T, Revaz S, Tschopp J. A pilot study of IL-1 inhibition by anakinra in acute gout. Arthritis
Res Ther. 2007;9(2):R28.
7: Terkeltaub R, Sundy JS, Schumacher HR, Murphy F, Bookbinder S, Biedermann S, Wu R, Mellis S, Radin
A. The interleukin 1 inhibitor rilonacept in treatment of chronic gouty arthritis: results of a placebo-controlled,
monosequence crossover, non-randomised, single-blind pilot study. Ann Rheum Dis. 2009 Oct;68(10):
1613-7.
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Gout and Other Chronic
Conditions
•  Patients suffering from gout have a high prevalence to
show multiple other chronic conditions (Exhibits 1 & 2)
•  Hypertension, Diabetes Type II, Chronic Kidney Disease (CKD),
Coronary Artery Disease (CAD), Congestive Heart Failure
(CHF), Gastrointestinal (GI) Tract
•  Existing gout treatments harbor moderate-strong
contraindications to multiple first-line gout medications
(Exhibit 3)
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Exhibit 1: High prevalence of comorbidities in patients with gout
The American Journal of Medicine, 2011 124, 155-163DOI: (10.1016/j.amjmed.2010.09.012)
Copyright © 2011 Elsevier Inc. See Terms and Conditions at http://www.elsevier.com/legal/elsevier-website-terms-and-conditions
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Exhibit 2: Patients with gout typically harbor multiple comorbidities
The American Journal of Medicine 2011 124, 155-163DOI: (10.1016/j.amjmed.2010.09.012)
Copyright © 2011 Elsevier Inc. See Terms and Conditions at http://www.elsevier.com/legal/elsevier-website-terms-and-conditions
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Exhibit 3: Patients with gout harbor moderate-strong contraindications
to multiple first-line gout medications
The American Journal of Medicine, 2011 124, 155-163DOI: (10.1016/j.amjmed.2010.09.012)
Copyright © 2011 Elsevier Inc. See Terms and Conditions at http://www.elsevier.com/legal/elsevier-website-terms-and-conditions
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Revive’s Solution
“REV-002” Indication: GOUT
The Drug: Bucillamine (being repurposed from RA to gout)
•  Arthritis drug marketed since 1980s in Japan and South Korea
•  Promising animal efficacy: lowered uric acid and inflammation (Dual-acting
treatment)
Patent Protected: PCT/CA2013/050882, until 2033
Market Potential: $1 billion + global sales for new gout drug
Partnership and Takeout Potential:
•  2012, US$1.28B: AstraZeneca/Ardea Biosciences for Lesinurad (no antiflare activity, uric acid lowering)
•  2012, US$800MM: Takeda/URL Pharma for Colcrys® (anti-flare activity)
Clinical Strategy: Preparing for Phase 2a clinical trial in the U.S in Q4/FY14
•  Results expected in Q1/FY15
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Bucillamine Anti-Inflammatory Mechanism:
Unique versus Current Drugs Used to Treat
Gouty Inflammation
•  NSAIDs, Colchicine, Corticosteroids:
•  Nonselective Therapeutic effects
•  Frequent and potentially serious adverse events, major organ
toxicity, and drug interactions
•  Bucillamine
•  Thiol-based inhibitor of inflammation signal transduction
(including NF-kB inhibition)
•  Limits multiple cytokine responses central to gouty inflammation
(including IL-1, IL-6, TNFalpha, synovial angiogenesis)
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Gout Treatment:
Bucillamine versus other drugs
Treatment Effect Flares More Adverse Events and Drug Interactions In: CAD/
Lower Uric
Diabetes
GI Tract
high
Hypertension CKD CHF Acid Type II Disease
lipids +/-­‐ Bucillamine Yes Yes Allopurinol/
Febuxostat No (+ more early flares) Colchicine Yes No Steroids Yes No + NSAIDs Yes No ++ +++ Yes (Allopurinol) ++ +++ ++++ ++ ++ + ++ + +++ ++++ ++++ • 
Bucillamine, as a repurposed drug, benefits from 20 + years of safety and contraindication data.
• 
Bucillamine belongs to a different class of drugs and has a different mechanism of action resulting in
a unique promising dual-therapeutic action and potential for lower adverse reactions in gout patients
19
Development Partnership
GOUT Partnership Potential
•  Partnership with Japanese Pharma
•  ~$1.4B sales, originator of bucillamine (Rimatil®)
•  Rapidly paves way for commercialization
•  Access to clinical, market, manufacturing info, drug supply
•  In return, Pharma secured Japan, Korea and Taiwan rights
•  Validation of market potential and intellectual property
•  Unlocks advantages of a new drug
•  Market exclusivity (i.e. USA and EU)
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Commercialization Path
•  Multi-center
•  120 subjects
•  Signs of anti-flare
activity & sUA lowering
Validation
•  Multi-center
•  24 to 66 subjects
•  Signs of anti-flare
activity & sUA lowering
Partnership
secured
Phase
IIA
Human safety
Manufacturing
Animal Efficacy
Non-clinical Tox
Discovery
Phase
IIB
Phase III
or
Partner
Ÿ
Ÿ
AstraZeneca
acquired ARDEA
(Lesinurad @
Phase III) for
$1.28 billion
Ÿ
Ÿ
Savings of $$
millions & ~5 years
of development
2014
2015
2016
2017
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2. Rett Syndrome
•  Orphan Disease Designation (< 200,000 people in US)
•  Rare disease affecting 16,000 in U.S. and 20,000 in EU
•  Experience loss of motor skills, seizures, respiratory
dysfunction
•  Girls are mostly affected
•  No cure for Rett Syndrome
•  Current therapies focus on symptoms management
•  26% of deaths due to respiratory arrhythmia
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Revive’s Solution
“REV-003” Indication: Rett Syndrome
The Drug: Tianeptine (being repurposed from anti-depressant)
•  Anti-depressant drug marketed since 1980s in Europe, Asia and South America
•  Focus on enhanced breathing, behavior, cognition, anti-seizure
Patent Protected: PCT/GB2013/051213, until 2033
Market Potential: $180-$360 million on unserved market
•  Low of 3,000 / max of 6,000 patients at $60,000 annual cost
Partnership and Takeout Potential:
•  PLI-T and CXR-T examples: orphan drugs are drawing attention from large pharma
•  Shire/ViroPharma acquisition (US$4.2 billon) for Cinryze in treatment of the Hereditary
angioedema rare disease
Clinical Strategy: Positive animal studies in respiratory rate
•  Orphan Drug Designation in Q1/FY15
•  Preparing for Phase 2a trial Q1/FY15
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Key Financial Information
Ticker Symbol
R V V (TSX Venture)
Share Price
$0.64 (October 8, 2014)
18,912,155 common shares
Capital Structure
775,206 stock options
590,000 @ $0.66 and 185,206 @ $0.30
Market Value
~ $12,000,000
Insider Ownership
58.1%
Cash and cash
equivalents
$1,188,919 (June 30, 2014)
Monthly Cash burn
~ $100,000
Analyst Coverage
Beacon Securities Limited – Doug Cooper, MBA
24
Investment Highlights
• 
Addressing large markets with unmet medical needs
•  Gout and Rett Syndrome (rare disease)
•  Repurposing existing and proven drugs/orphan drugs focus
• 
De-risked later-stage clinical assets
•  Known safety (clinical/market use)
•  Patent protection to 2030’s
• 
Secured Pharma development partner for gout
•  Market validation and reduced development risk/cost
• 
Clear path to commercialization
•  Driven by phase II data and partnerships
• 
Significant near-term catalysts unlocking value
25